The present invention particularly relates to an irrigation apparatus including a small, hand-held instrument for providing of a continuous or intermittent flow of cleaning and/or sterilizing liquid to a wound and particularly during various surgical procedures and particularly to such a hand-held instrument and apparatus having an appropriate regulated pressure and flow to insure proper functioning without damage to the patient's tissue.
During surgery, irrigation systems are provided for spraying the surgical area, including the patient's tissue and bones within the surgical area with an appropriate sterilizing and/or cleansing liquid solution. The solution further maintains a moist tissue to facilitate the surgical procedure and to optimize post surgical recovery. Often the instruments provided may also include an aspirating device for removal of blood, debris, excess fluid and the like. Such irrigation systems have also been suggested in connection with treatment of wounds generally prior to closure. The subject matter is discussed in some detail in a paper entitled "High-Pressure Wound Irrigation" and presented by Hal Rogness, R.N. BSN, ET, of Berkeley, Calif. in J. Enterostom Ther at a presentation on Dec. 27, 28, 1985. The paper presented includes a bibliography of various other publications relating to wound irrigation. As discussed in that reference, the present technology has considered three alternate methods of irrigation including a high pressure variety using a pulsating jet, and alternatively, a gravity drip application or a conventional bulb syringe application to the wound. A prior paper entitled "Evaluation Of Wound Irrigation By Pulsatile Jet And Conventional Methods" published in Volume 187, No. 2 of the American Surgical Journal in 1977 includes a statistical analysis with respect to the above three systems and no irrigation. As presented in the above papers, the general conclusion appears to be that the pulsating jet is a relatively high pressure jet providing good results in various applications but presents a continuing problem of possible tissue trauma. The papers also indicate that in the conventional methods described, adequate flow control and application of the solution while maintaining flow by the operator all present significant difficulties or problems in the field of irrigation, even though in practically all instances, irrigation is highly desirable and universally used. Various hand-held devices have also been suggested for delivery of the fluid to the wound area during surgery and the like. The various disclosures known to applicant all use powered liquid solution fluid sources such as generally discussed in the articles including wall mounted pressure and hand-held syringes with either a bulb pump or a plunger pump mechanism which are manually actuated to affect the surgical irrigation. Such units include hand-held syringe units which may have detachable nozzle members for delivering the fluid to limited areas by the operator during the surgical operation.
Thus, prior art patents have discussed various forms of surgical irrigating devices. A pressurized can device, for example, is disclosed in U.S. Pat. No. 5,133,701 which issued Jul. 28, 1992. In this patent, a small hand-held can type container is provided with an upper discharge valved nozzle. The can is pressurized, with discharge of the liquid through a valved nozzle. U.S. Pat. No. 5,178,606 discloses an irrigation and aspiration apparatus for application within a patient's remote cavity for endoscopic surgery, with a separate control for closely controlling the pressure and temperature of the liquid. The system establishes a hemostatic effect during the surgical process and thus provides a very specific application for a cavity surgical process. A pressurized system has also been disclosed to create a jet using a high pressure stream of appropriate sterilized saline solution to produce a cutting and knife action within the surgical area. For example, U.S. Pat. No. 4,913,698 which issued Apr. 3, 1990 discloses a high pressure jet device functioning as knife use during brain surgery. In this patent, a flexible container is housed within a high pressure container, with a nitrogen source coupled to the container to pressurize the container to a high level. The output is applied to a nozzle device having a small passage to generate a high pressure jet knife producing fine line incisions for crushing and removing brain tumors in cerebral surgery.
More recently, the present inventors have received information of a battery operated pumping system for delivery of a liquid solution for irrigating a wound area. Although identified as a throw-away unit, the unit is understood to cost about fifty dollars.
The most conventional method for wound irrigation is the hand-held syringe which has a limited volume of liquid and the pressure pump such as a piston or a bulb which is operated to directly generate a flow of liquid to the surgical area. The flow rate and pressure are of course directly related to and controlled by the particular skill of the operator in actuating of the pressurizing element. Thus, the operator's attention is directed to both creating the flow by operation of the syringe and directing the resulting flow into the required wound area. In addition, the syringe does not include a continuous solution source and must be periodically filled with the liquid solution.
Thus, various known systems provide hand-held tools which apply a liquid solution. However, each system has known difficulty in providing the desired pressure and flow application of the liquid to the wound area particularly during a surgical procedure.
In summary, hand-held jet devices have been widely used in surgical procedures for various reasons including those for applying a liquid to a wound. Generally, prior art wound moisturizing and cleansing device, however, include a drip bag, a syringe applicator or a pulsating jet device such as discussed above. The prior devices have been available for surgical procedures and the problems associated therewith known for many years.
There is therefore a significant need and demand for a simple, portable apparatus which can be supplied during a surgical procedure with a continuous flow of liquid solution from an assured source of the necessary solution while permitting the convenient and reliable functioning and operation of the apparatus by the operator.